FDA

The US Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety and efficacy of a broad range of products used by US consumers. Its regulatory authority extends from food and drugs to medical devices, biologics, blood, vaccines, animal and veterinary medicines, cosmetics, combination products and radiation-emitting technologies. 

To fulfill its mandate to protect the public health, the FDA is charged with issuing and enforcing regulations for the research, development, production or processing, distribution, marketing and potential adverse effects of any regulated product for US consumers. The FDA is responsible for regulated activities in thousands of facilities in the US and overseas, and for millions of pounds of products that are imported into the US each year.

Our FDA Training Solution

UL's learning management solutions, developed in collaboration with the FDA, support compliance within each of the FDA’s areas of responsibility. 

Our FDA training solutions span the life cycle of each product, from clinical site training through GMP training, distribution, sales and adverse event training and post-marketing oversight. Throughout all these stages, we help organizations meet compliance requirements as diverse as GLPs and GMPs, employee safety, patient confidentiality, and adverse event reporting.

UL maintains a unique partnership with FDA, under which we provide the online FDA training, documentation and a 21 CFR Part 11-validated technology system, known as ComplianceWire®, for “ORA U,” FDA’s virtual university. The FDA uses ORA U to train and certify its 30,000 federal, state and local investigators in the areas of quality and compliance.

Our FDA Training Content

More than 120 UL courses for food, pharmaceuticals and medical device quality practices have been written for review by the FDA under our partnership. The same courses and technology system used by the FDA are available to UL’s clients. We recently expanded the partnership with the FDA to provide non-US government agencies with access to our FDA training solution.